Postoperative PainPhase 4CARANNCT00738192
Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia
A Phase 4 study testing Fentanyl citrate, Sufentanil citrate and Butorphanol tartrate in people with Postoperative Pain, run by Nanjing Medical University at 1 site in China.
Trial summary
Fast awakening from anesthesia is one of the major characteristics of remifentanil-associated anesthetic induction and maintenance, whereas corresponding pain during awakening influences patient's rehabilitation strongly. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Fentanyl citrate, Sufentanil citrate and Butorphanol tartrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Jul 2008to Mar 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status I-II
- Chinese
- 19-45yr
- Selective laparoscopic surgeries
Who cannot join
- Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
- Participants younger than 18 years, older than 45 years or pregnancy was eliminated
- Due to the significant changes in vital signs might affect cognition of pain and that of sensation, over 20% variation of these records from the baselines or below 92% of SpO2 under 20-40% nasal tube oxygen at any time should be excluded from the study
- Those who were not willing to or could not finish the whole study at any time
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, 210004
About this study
Official title: Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia in Gynecological Laparoscopic Surgeries
Fast awakening from anesthesia is one of the major characteristics of remifentanil-associated anesthetic induction and maintenance, whereas corresponding pain during awakening influences patient's rehabilitation strongly. In addition, such early postoperative pain results in significant stress responses, which displays as further release of stress hormones such as cortisol and β-endorphin as well. How to prevent such acute pain resulting from remifentanil's fast metabolism endows clinical significance. This study is designed to compare the analgesic efficacy of fentanyl, sufentanil and butorphanol delivered after gynecological laparoscopic surgeries that underwent remifentanil induction and maintenance, and investigate corresponding influence on the levels of blood cortisol and β-endorphin.
- Conditions
- Postoperative Pain
- Being tested
- Fentanyl citrate, Sufentanil citrate, Butorphanol tartrate
- Keywords
- Postoperative analgesia, Opioids, Laparoscopic surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl citrateDrug
Also called Fentanil
Fentanyl 0.5 μg/kg delivered intravenously immediate at the end of remifentanil pump finished
Sufentanil citrateDrug
Also called Sufenil
Sufentanil 0.05 μg/kg delivered intravenously immediate at the end of remifentanil pump finished
Butorphanol tartrateDrug
Also called Nuoyung
Butorphanol 0.01 mg/kg delivered intravenously immediate at the end of remifentanil pump finished
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Fentanyl delivered for controlling awaking pain Receives: Drug: Fentanyl citrate |
| 2 | Active comparator | Sufentanil delivered for controlling awaking pain Receives: Drug: Sufentanil citrate |
| 3 | Active comparator | Butorphanol delivered for controlling awaking pain Receives: Drug: Butorphanol tartrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS ratings of pain
Measured: 0 min after awake from anesthesia; 5,10,15,20 and 30min after awake from anesthesia
Secondary outcomes (5)
Hemodynamics of patients
Measured: 30min before operation; every 10min during operation; 5,10,15,20,30 and 60min after operation
Sedative ratings with VAS system
Measured: 0,5,10,15,25,45 and 60min after awake from anesthesia
Overall VAS satisfaction ratings
Measured: 1 h after operation
Blood cortisol and β-endorphin levels
Measured: 0, 10min before the end of surgeries, 10min, 1h and 6h after operation
Side effects
Measured: 1 h after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Investigators
- XiaoFeng Shen, MD, Study chair, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738192
- Sponsor's protocol ID
- NMU-FY2008-311
- Other IDs
- NJFY0807311M
- Acronym
- CARAN
- Status last verified
- Mar 2009
- First submitted
- 18 Aug 2008
- Last updated
- 11 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia in Gynecological Laparoscopic Surgeries
- ClinicalTrials.gov ID
- NCT00738192
- Acronym / sponsor ID
- CARAN / NMU-FY2008-311
- Conditions
- Postoperative Pain
- Keywords
- Postoperative analgesia, Opioids, Laparoscopic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 20 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fast awakening from anesthesia is one of the major characteristics of remifentanil-associated anesthetic induction and maintenance, whereas corresponding pain during awakening influences patient's rehabilitation strongly. In addition, such early postoperative pain results in significant stress responses, which displays as further release of stress hormones such as cortisol and β-endorphin as well. How to prevent such acute pain resulting from remifentanil's fast metabolism endows clinical significance. This study is designed to compare the analgesic efficacy of fentanyl, sufentanil and butorphanol delivered after gynecological laparoscopic surgeries that underwent remifentanil induction and maintenance, and investigate corresponding influence on the levels of blood cortisol and β-endorphin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Fentanyl citrateFentanyl delivered for controlling awaking pain |
| 2 | Active comparator | Drug: Sufentanil citrateSufentanil delivered for controlling awaking pain |
| 3 | Active comparator | Drug: Butorphanol tartrateButorphanol delivered for controlling awaking pain |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA physical status I-II
- Chinese
- 19-45yr
- Selective laparoscopic surgeries
Key exclusion criteria (4 listed)
- Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
- Participants younger than 18 years, older than 45 years or pregnancy was eliminated
- Due to the significant changes in vital signs might affect cognition of pain and that of sensation, over 20% variation of these records from the baselines or below 92% of SpO2 under 20-40% nasal tube oxygen at any time should be excluded from the study
- Those who were not willing to or could not finish the whole study at any time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl citrateAlso: FentanilFentanyl 0.5 μg/kg delivered intravenously immediate at the end of remifentanil pump finished | Drug | 1 |
| Sufentanil citrateAlso: SufenilSufentanil 0.05 μg/kg delivered intravenously immediate at the end of remifentanil pump finished | Drug | 2 |
| Butorphanol tartrateAlso: NuoyungButorphanol 0.01 mg/kg delivered intravenously immediate at the end of remifentanil pump finished | Drug | 3 |
Primary outcome
VAS ratings of pain
Time frame: 0 min after awake from anesthesia; 5,10,15,20 and 30min after awake from anesthesia
5 secondary outcomes
Hemodynamics of patients
Time frame: 30min before operation; every 10min during operation; 5,10,15,20,30 and 60min after operation
Sedative ratings with VAS system
Time frame: 0,5,10,15,25,45 and 60min after awake from anesthesia
Overall VAS satisfaction ratings
Time frame: 1 h after operation
Blood cortisol and β-endorphin levels
Time frame: 0, 10min before the end of surgeries, 10min, 1h and 6h after operation
Side effects
Time frame: 1 h after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
XiaoFeng Shen, MD study chair
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl citrate, Sufentanil citrate and Butorphanol tartrate in people with Postoperative Pain, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS ratings of pain (time frame: 0 min after awake from anesthesia; 5,10,15,20 and 30min after awake from anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2009.